Talaris Therapeutics is a late-clinical stage cell therapy company that is developing an innovative method of allogeneic stem cell transplantation that we believe has the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases and certain severe non-malignant blood, immune and metabolic disorders. In the organ transplant setting, which is our initial focus, we believe that our proprietary therapeutic approach could prevent organ rejection without the consequences associated with the use of chronic immunosuppression.
Our initial focus is on living donor kidney transplant (LDKT). Long-term outcomes in LDKT are suboptimal due to the complications associated with chronic immunosuppression including:
We believe FCR001 has the potential to establish persistent allogeneic tolerance in LDKT recipients to their transplanted organ, thereby permitting the LDKT recipient to discontinue all chronic immunosuppression within ~12 months of their transplant, without rejecting the transplanted organ. FCR001 has been granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) in this indication.